A Phase 3 interventional study of Inclisiran and Placebo in Heterozygous Familial Hypercholesterolemia and Elevated Cholesterol, sponsored by The Medicines Company. Completed at 45 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by The Medicines Company (part of Novartis) · Phase 3, Interventional, and Treatment
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Among 24 studies testing inclisiran in Hypercholesterolemia — 6 open to participants now, 10 under way, 5 of them phase 3. inclisiran · Hypercholesterolemia.
Among the 24 studies testing inclisiran in Hypercholesterolemia, this one is the 9th largest by enrollment, is one of 3 that started in 2017, is one of 13 in phase 3, and was the 2nd registered.
1,177 studies on the registry are indexed under Hypercholesterolemia; 95 are open to participants now.
Browse Hypercholesterolemia studies →6 of the 24 studies testing inclisiran in Hypercholesterolemia are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States
Ages 18–75
University Medical Centre Ljubljana · Sites in Slovenia
Ages 18+
Duke University · Sites in United States
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Austria, China and 8 more countries
Ages 2–11
Novartis Pharmaceuticals · Sites in Argentina, Brazil
Ages 18–100
By country, each count listing its studies:
inclisiran: first FDA approval 2021 (LEQVIO), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 55 Hypercholesterolemia studies recruiting now, 23 (42%) set no upper age limit and 20 (36%) stop at 75 or younger; 9 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 482 is above the median of 110 across 976 interventional studies indexed under Hypercholesterolemia.
Median enrollment 375 across the 24 interventional studies. Of the 14 that completed or were terminated, 10 (71%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 24 have an industry lead sponsor. The 6 most frequent:
This study is registered under The Medicines Company, one of the names counted as Novartis. Under that name alone:
The Medicines Company is the lead sponsor of 50 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
36 studies in Hypercholesterolemia by Novartis: 6 open now, 11 under way, 5 of them phase 3. Of 25 finished, 10 (40%) have results posted.
Among the 36 studies in Hypercholesterolemia by Novartis, this one is the 9th largest by enrollment of the 26 interventional ones that give a count, is one of 3 that started in 2017, is one of 17 in phase 3, and was the 8th registered.
Novartis’s Hypercholesterolemia studies by the year they started, since 2002.
5 of the studies testing inclisiran in Hypercholesterolemia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05030428Phase 3Novartis PharmaceuticalsStudy of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease | 2027-05-10 |
| NCT06501443Novartis PharmaceuticalsLATAM LOWERS LDL-C | 2026-11-27 |
| NCT06249165Duke UniversityVictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease | 2026-12-31 |
| NCT07610278Novartis PharmaceuticalsA Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia | 2027-04-28 |
| NCT07581808University Medical Centre LjubljanaDual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention | 2027-05 |
Add all 5 to your calendar (.ics) → With an account.
Among the 24 studies testing inclisiran in Hypercholesterolemia, from their registry updates:
Among Novartis’s 36 in Hypercholesterolemia:
This tab as a report to print or save as PDF → With an account.
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants may be included if they meet all of the following inclusion criteria prior to randomization:
Exclusion Criteria:
Participants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:
Females who are pregnant or nursing, or who are of and unwilling to use at least 2 methods of highly effective (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.
Drug: Inclisiran
Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.
Drug: Placebo
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Also known as: Saline Solution
Percent Change in LDL-C From Baseline To Day 510
Time frame: Baseline, Day 510
Time-adjusted Percent Change in LDL-C From Baseline After Day 90 and up to Day 540
Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 90 reported
Time frame: Baseline, Day 90
Absolute Change in LDL-C From Baseline to Day 510
Time frame: Baseline, Day 510
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540
Assessments performed at Baseline, Day 90, Day 540, absolute change at Day 90 reported
Time frame: Baseline, Day 90
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510
Time frame: Baseline, Day 510
Percentage Change in Total Cholesterol From Baseline to Day 510
Time frame: Baseline, Day 510
Percent Change in Apolipoprotein B (Apo-B) From Baseline To Day 510
Time frame: Baseline, Day 510
Percent Change in Non-high-density Lipoprotein (HDL)-C From Baseline To Day 510
Time frame: Baseline, Day 510
| Milestone | Inclisiran | Placebo |
|---|---|---|
| Started | 242 | 240 |
| Completed | 235 | 231 |
| Not completed | 7 | 9 |
| percent change | Inclisiran | Placebo |
|---|---|---|
| Percent Change in LDL-C From Baseline To Day 510 | -41.15 (-44.52 to -37.77) | 8.37 (3.96 to 12.77) |
Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 90 reported
| percent change | Inclisiran | Placebo |
|---|---|---|
| Time-adjusted Percent Change in LDL-C From Baseline After Day 90 and up to Day 540 | -38.08 (-41.03 to -35.14) | 6.22 (3.26 to 9.17) |
| mg/dL | Inclisiran | Placebo |
|---|---|---|
| Absolute Change in LDL-C From Baseline to Day 510 | -58.95 (-64.75 to -53.15) | 9.94 (4.10 to 15.78) |
Assessments performed at Baseline, Day 90, Day 540, absolute change at Day 90 reported
| mg/dL | Inclisiran | Placebo |
|---|---|---|
| Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540 | -56.58 (-60.98 to -52.17) | 6.17 (1.72 to 10.62) |
| percent change | Inclisiran | Placebo |
|---|---|---|
| Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510 | -60.68 (-64.40 to -56.96) | 17.66 (13.91 to 21.42) |
| percent change | Inclisiran | Placebo |
|---|---|---|
| Percentage Change in Total Cholesterol From Baseline to Day 510 | -25.11 (-27.83 to -22.39) | 6.66 (3.96 to 9.36) |
| percent change | Inclisiran | Placebo |
|---|---|---|
| Percent Change in Apolipoprotein B (Apo-B) From Baseline To Day 510 | -33.14 (-35.91 to -30.36) | 2.93 (0.14 to 5.71) |
| percent change | Inclisiran | Placebo |
|---|---|---|
| Percent Change in Non-high-density Lipoprotein (HDL)-C From Baseline To Day 510 | -34.93 (-38.46 to -31.40) | 7.43 (3.93 to 10.92) |
Collected over Day 0 - 510. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inclisiran | 1/241 (0.4%) | 18/241 (7.5%) | 96/241 (39.8%) |
| Placebo | 1/240 (0.4%) | 33/240 (13.8%) | 67/240 (27.9%) |
| Event | Inclisiran | Placebo |
|---|---|---|
| Angina unstableCardiac disorders | 1/241 | 4/240 |
| Myocardial ischaemiaCardiac disorders | 1/241 | 3/240 |
| Optic ischaemic neuropathyEye disorders | 0/241 | 2/240 |
| Back painMusculoskeletal and connective tissue disorders | 0/241 | 2/240 |
| Acute myocardial infarctionCardiac disorders | 2/241 | 1/240 |
| Aortic valve stenosisCardiac disorders | 2/241 | 0/240 |
| Arteriosclerosis coronary arteryCardiac disorders | 0/241 | 1/240 |
| Atrial fibrillationCardiac disorders | 0/241 | 1/240 |
| Supraventricular tachycardiaCardiac disorders | 0/241 | 1/240 |
| Gastritis erosiveGastrointestinal disorders | 0/241 | 1/240 |
| Event | Inclisiran | Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 28/241 | 20/240 |
| Injection site reactionGeneral disorders | 22/241 | 0/240 |
| InfluenzaInfections and infestations | 13/241 | 21/240 |
| Back painMusculoskeletal and connective tissue disorders | 17/241 | 10/240 |
| Upper respiratory tract infectionInfections and infestations | 16/241 | 16/240 |
| Age, Categorical(Participants) | Inclisiran | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 189 | 185 | 374 |
| >=65 years | 53 | 55 | 108 |
| Age, Continuous(years) | Inclisiran | Placebo | Total |
|---|---|---|---|
| Mean | 54.4 ± 12.48 | 55.0 ± 11.81 | 54.7 ± 12.14 |
| Sex: Female, Male(Participants) | Inclisiran | Placebo | Total |
|---|---|---|---|
| Female | 130 | 125 | 255 |
| Male | 112 | 115 | 227 |
| Ethnicity (NIH/OMB)(Participants) | Inclisiran | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 8 | 15 |
| Not Hispanic or Latino | 235 | 232 | 467 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Inclisiran | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 7 | 5 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 8 | 7 | 15 |
| White | 226 | 227 | 453 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Inclisiran | Placebo | Total |
|---|---|---|---|
| Canada | 12 | 11 | 23 |
| Netherlands | 19 | 19 | 38 |
| Sweden | 18 | 16 | 34 |
| United States | 33 | 32 | 65 |
| Czechia | 7 | 5 | 12 |
| Denmark | 23 | 26 | 49 |
| South Africa | 88 | 89 | 177 |
| Spain | 42 | 42 | 84 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Aug 2019, 20 months.
Results were first posted in Oct 2020, 1 year 2 months after primary completion.
Of 122 industry-sponsored phase 3 interventional studies under Hypercholesterolemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 20 months is above that.
Counting every sponsor, half of 125 studies reached it within 18 months; a quarter within 10 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Inclisiran